Batch Record Reviewer / QA QC Inspector

Description

Work Schedule:

Monday through Friday, 8:00 AM to 4:30 PM.

Description:

• Review processing batch records for compliance with all specified requirements and procedures.
• Make final determination regarding suitability of LifeCell products for final release of a lot to Finished Goods and/or other dispositions, including rejections.
• Work closely with Manufacturing and Quality to resolve any discrepancies uncovered during batch records review.
• Generate Certificate of Conformances as deemed necessary.
• Initiate reworks when applicable for nonconforming product to ensure they are conforming
• Quarantine product as deemed necessary for identified non-conforming product.
• Complete transactions as deemed necessary for acceptable or non-conforming product.
• Compile and perform trending of issues encountered at batch record review to identify any drift in performance or potential issues.
• Confirm research consent for lots designated for marketing, research or validation purposes
• Investigate Non-conformance’s and CAPA’s.
• Assist Supervisor with various projects and metrics as deemed necessary.
• Initiate change controls for the department. (ECO’s)

Top 5 Skills/Experience/Education required for this position:

• Associate or Bachelors preferred
• Detail oriented
• GMP experience preferred
• Critical thinking
• Effective Communicator